eCTD TEMPLATE AUTOMATION

ONIX eCTD template suite developed to simplify the eCTD writing process

Drive efficiency with predefined eCTD template suite to enable compliant submission documents. ONIX eCTD templates remove the uncertainty so clients can concentrate on the content.

WORD eCTD TEMPLATE AUTOMATION

The creation of documents for an eCTD application is a time-consuming process, involving many different authors working with numerous documents. The resulting documents are often inconsistent in appearance and format, which leads to a lengthy internal review process to finalise and approve documents.
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ONIX eCTD template suite provides:

Granular Module 1 to 5 templates

Pre-populated metadata

Pre-defined headings with eCTD numbering

Tables with eCTD numbering

Headers & footers implemented for portrait & landscape pages

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The templates provide a common structure with an easy-to-use ONIX toolbar to standardise the formatting in a one-click approach, for tasks including:

  • Apply commonly used styles
  • Batch update on metadata across all documents
  • Create tables
  • Insert cross-references
  • Switch page orientation to retain headers and footers
  • Copy and paste text from other sources in correct format
  • Generate tables of contents

Implementing the ONIX template suite streamlines the process and results in consistent formatted documents, which are easy to review, and saves the author time and effort.

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